RecruitingNCT02507141

Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

140 participants

Start Date

Jul 21, 2015

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to get images (pictures) of oral lesions, which occur inside the mouth, before the patient's surgery using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. The technology is called "reflectance confocal microscopy." We would like to compare what the camera sees to biopsies (pathology) of the same area. We will evaluate the pictures obtained from the patient to determine whether this technology may be useful in the future. We hope this technology can be used as a tool for early diagnosis of oral cancers and for guiding surgery.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Patients with biopsy-proven oral SCC who are scheduled to undergo surgery in the MSK Head and Neck Service.
  • Ability to sign informed consent.
  • Age ≥ 18 years.

Exclusion Criteria2

  • Cancer located on a site that may not be convenient or accessible for imaging with the current version of the RCM device (gingivobuccal region, back of the oral cavity, back of the tongue, floor of the mouth, deep under the tongue, etc.).
  • Inability to give informed consent.

Interventions

DEVICEReflectance Confocal Microscopy

Reflectance Confocal Microscopy imaging will be performed during surgery. The imaging procedure is expected to last no more than 15-20 minutes. The approach will be essentially similar to the imaging of skin cancer on patients, which is routinely performed in our Dermatology Service.


Locations(5)

Memorial Sloan Kettering Basking Ridge (consent only)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (consent only)

Middletown, New Jersey, United States

Memorial Sloan Kettering West Harrison (consent only)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (consent only)

Uniondale, New York, United States

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NCT02507141


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